Midazolam Nasal Spray Safety and Efficacy Results Reported

Tuesday, December 04, 2018

In results presented at the American Epilepsy Society’s annual meeting in New Orleans, LA, midazolam nasal spray (USL261; UCB, Atlanta, GA), a drug being investigated for treatment of acute repetitive seizures (ARS), was shown safe and effective in open-label phase 3 extension (NCT01529034) of the ARTEMIS-1 study (NCT01390220). 

Of patients who completed the pivotal trial, 87% (n = 175) enrolled in the open-label extension and 161 used midazolam to treat ARS at least once. A total of 1,998 episodes of ARS were treated with 1 or 2 intranasally delivered 5 mg doses of midazolam; 55.5% (1,108; 95% CI: 53.2%-57.7%) of seizures stopped within 10 minutes and did not recur for 6 hours after a single dose and approximately 30% met that criteria after 2 doses. Occurrence of adverse events was approximately 28% and no serious adverse events were classified as related to the midazolam. Mild adverse events included convulsion (2.5%), dizziness (2.5%), fatigue (4.3%), headache (6.2%), lacrimation (2.5%), nasal discomfort (12.4%), nausea (2.5%), rhinorrhea (4.3%), somnolence (9.3%), sneezing (3.7%). 

In another study, consisting of retrospective review of 484 charts, investigators reviewed use in matched samples of patients treated with intranasal midazolam (n = 23) or intravenous lorazepam (n = 27) for rescue from acute seizure in an epilepsy monitoring unit. They found no difference in time to drug administration (=.15) and no difference in time to recurrent seizure (= .10) between the groups, suggesting that intranasal midazolam is as effective as intravenous lorazepam for treatment of prolonged seizures or ARS in the epilepsy monitoring unit. No differences in documented adverse events were seen between the 2 groups. 

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